Skip to main content
OpenTrials
Completed

NCT Number: NCT02772900

Aging, Nitrate, Endothelial Function and Muscle Oxygenation

Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO bioconversion, which may promote beneficial effects on vascular health. The present study evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ), augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), muscle oxygenation and function were measured 90 min after interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after interventions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Abdominal Obesity Body Weight Cardiovascular Diseases Dyslipidemia Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly participants (≥ 65 years)
  • Taking between 1 and 3 anti-hypertensive medications for high blood pressure;
  • Elevated triglycerides ≥ 150 mg/dL;
  • Reduced HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men;
  • Elevated waist circumference by population definition (male: > 102 cm and female: > 88 cm).

Exclusion criteria

elevated fasting glucose (≥ 100 mg/dL), smoking, beetroot allergy, unwillingness to avoid beetroot products during the entire study, other chronic diseases (diabetes, liver disease, etc.), or acutely ill.

Treatment and study plan

Beetroot-based nutritional gel

Other

100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.

Placebo

Other

100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

Primary outcomes

  1. Changes in endothelial function as evaluated by the flow-mediated dilation.

    Time frame: Evaluated 120 min after the nutritional intervention

  2. Changes in the arterial stiffness as evaluated by the peak wave velocity.

    Time frame: Evaluated 120 min after the nutritional intervention

  3. Changes in the clinical blood pressure

    Time frame: Evaluated before, 120 min and 180 min after the nutritional intervention

  4. Changes in the muscle oxygenation as evaluated by the levels of oxygenated

    Time frame: Evaluated 150 min after the nutritional intervention

  5. Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle

    Time frame: Evaluated before and 180 min after the nutritional intervention

  6. Changes in endothelial function as evaluated by blood flow velocity

    Time frame: Evaluated 120 min after the nutritional intervention

  7. Changes in endothelial function as evaluated by reactive hyperemia.

    Time frame: Evaluated 120 min after the nutritional intervention

  8. Changes in the arterial stiffness as evaluated by augmentation index

    Time frame: Evaluated 120 min after the nutritional intervention

  9. Changes in the arterial stiffness as evaluated by the stiffness parameter

    Time frame: Evaluated 120 min after the nutritional intervention

  10. Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus

    Time frame: Evaluated 120 min after the nutritional intervention

  11. Changes in the arterial stiffness as evaluated by the arterial compliance.

    Time frame: Evaluated 120 min after the nutritional intervention

  12. Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin

    Time frame: Evaluated 150 min after the nutritional intervention

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 16, 2016
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.